FDA 510(k)

皮科夾

K 號：K230281 · 2023-10-23

決定日期2023-10-23

產品代碼DXC

諮詢委員會履歷

決定相當於

器材摘要

PICOCLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Kono Seisakusho Co., Ltd.. It received FDA 510(k) clearance on 2023-10-23 under 510(k) number K230281. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the PICOCLAMP?

PICOCLAMP is a medical device that received FDA 510(k) clearance on 2023-10-23. The listed applicant is Kono Seisakusho Co., Ltd.. The 510(k) number is K230281.

When did PICOCLAMP receive FDA 510(k) clearance?

PICOCLAMP received FDA 510(k) clearance on 2023-10-23, under 510(k) number K230281.

Who is the listed applicant for PICOCLAMP?

The FDA 510(k) record lists Kono Seisakusho Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICOCLAMP?

The FDA product code for PICOCLAMP is DXC.

其他以 Kono Seisakusho Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K192420Crownjun 尼龍縫線

相關器械（代碼：DXC）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K262086PreludeSYNC™ 徑向壓縮設備Merit Medical Systems, Inc.K260105Fogarty 強力夾釘，無把柄夾具，及夾具插片Edwards Lifesciences K252772Arc 可調節放射狀袖口壓縮設備Tz Medical, Inc.K254060救命止血帶TW Medical K243627喉鏡節段性動脈限制夾 (L-ARC)；動脈限制夾 (ARC)Arc Trauma, LLC K253070Namic 放射臂帶，23 公分（DYNJRADBAND）；Namic 放射臂帶，26 公分（DYNJRADBANDL）Medline Industries, LP

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。